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臭氧水漱口用于非角化型鼻咽癌放射性口腔黏膜炎:一项回顾性队列研究

Ozonated water mouthrinse for radiation-induced oral mucositis in non-keratinizing nasopharyngeal carcinoma: a retrospective cohort study.

临床研究鼻咽癌IF 3.7Q1

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中文摘要

目的: 评估在接受放疗的鼻咽癌(NPC)患者中,有记录的臭氧水(OW)漱口与放疗诱导的口腔黏膜炎(OM)结局之间的关联。
方法: 一项单中心回顾性队列研究纳入65例接受根治性放化疗的NPC患者。其中34例在放疗期间有记录的OW漱口,31例作为无记录OW使用的对照。主要终点为首次发生WHO ≥2级OM的时间。由于OW开始使用时间具有时变性,采用时间依赖Cox分析和landmark分析作为主要的时间感知方法,并保留基于倾向性评分的模型作为支持性关联分析。次要结局包括第15次和第30次分次时≥2级OM的发生率、峰值口腔疼痛评分以及放疗结束后黏膜愈合间隔。
结果: OW开始使用的中位分次为2.5(IQR 1-4.75;范围F1-F22)。在时间感知分析中,有记录的OW暴露与首次≥2级OM风险降低相关,时间依赖Cox模型(HR 0.35,95% CI 0.20-0.63;P < 0.001)和10次分次landmark分析(HR 0.47,95% CI 0.26-0.83;P = 0.010)均显示此关联。支持性的固定曾使用倾向性评分分析方向一致,包括稳定化IPTW模型(HR 0.48,95% CI 0.27-0.88;P = 0.018)。在第30次分次时,OW组50.0%的患者与对照组90.3%的患者发生≥2级OM。OW组还报告了较低的峰值口腔疼痛(P < 0.01),以及放疗结束后黏膜愈合间隔缩短的非显著趋势。
结论: 在这项回顾性NPC队列中,放疗期间有记录的OW漱口与较低的OM负担和口腔疼痛减轻相关。鉴于观察性设计、时变暴露、残余混杂以及基于病历的暴露和结局判定,这些发现应解释为探索性关联,需要前瞻性验证。

英文摘要

PURPOSE: To evaluate the association between documented ozonated water (OW) mouthrinsing and radiotherapy-induced oral mucositis (OM) outcomes in patients with nasopharyngeal carcinoma (NPC).
METHODS: A single-center retrospective cohort study included 65 NPC patients receiving definitive chemoradiotherapy. Among them, 34 had documented OW mouthrinsing during radiotherapy and 31 served as controls without documented OW use. The primary endpoint was time to first WHO grade ≥ 2 OM. Because OW initiation was time-varying, time-dependent Cox and landmark analyses were used as the main time-aware approaches, with propensity score-based models retained as supportive association analyses. Secondary outcomes included the incidence of grade ≥ 2 OM at fractions 15 and 30, peak oral pain scores, and post-EoRT mucosal healing interval.
RESULTS: OW initiation occurred at a median fraction of 2.5 (IQR 1-4.75; range F1-F22). In time-aware analyses, documented OW exposure was associated with a lower hazard of first grade ≥ 2 OM in both the time-dependent Cox model (HR 0.35, 95% CI 0.20-0.63; P < 0.001) and the 10-fraction landmark analysis (HR 0.47, 95% CI 0.26-0.83; P = 0.010). Supportive fixed ever-use propensity score-based analyses were directionally consistent, including the stabilized IPTW model (HR 0.48, 95% CI 0.27-0.88; P = 0.018). At fraction 30, 50.0% of OW patients versus 90.3% of controls had grade ≥ 2 OM. The OW group also reported lower peak oral pain (P < 0.01) and a nonsignificant trend toward a shorter post-EoRT mucosal healing interval.
CONCLUSION: Documented OW mouthrinsing during radiotherapy was associated with lower OM burden and reduced oral pain in this retrospective NPC cohort. Given the observational design, time-varying exposure, residual confounding, and chart-based exposure and outcome ascertainment, these findings should be interpreted as exploratory associations requiring prospective validation.